Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,125 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 26, 2014 Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instrume... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 26, 2014 Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments ar... An investigation identified that high level friction may exist between the needle and Mamba sutur... Class II Biomet, Inc.
Sep 24, 2014 Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a varie... An investigation identified that the product was incorrectly manufactured as a left humeral trial... Class II Biomet, Inc.
Sep 17, 2014 Compress Face Reamer Product Usage: Correction of revision of unsuccess... Investigation determined that units supplied were missing the 4x21 degree helix angle. Class II Biomet, Inc.
Sep 5, 2014 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... The software issue described was corrected in the modification to the MXTTOUT controller paramete... Class II Zimmer Biomet, Inc.
Jul 1, 2014 Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... Class II Biomet, Inc.
Jun 23, 2014 Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... Class II Biomet, Inc.
Jun 4, 2014 ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... Software corrections reactivating the cooperative endoscopy mode. Class II Zimmer Biomet, Inc.
May 15, 2014 DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT T... Surface finish is different than specified. The implant has 30 grit blast on the exterior of the... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument fo... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument f... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
Apr 22, 2014 ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesi... This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge r... Class II Biomet, Inc.
Apr 15, 2014 EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthope... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunc... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manu... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Feb 26, 2014 Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biom... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 26, 2014 Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique an... Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was ide... Class II Biomet, Inc.
Feb 26, 2014 Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Bi... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 14, 2014 ROSA Surgical Device 2.5.8. It is intended to be used in the operating ro... An undetected shift between the information displayed in the navigation software and the actual p... Class II Zimmer Biomet, Inc.
Dec 19, 2013 Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified ... Class II Biomet, Inc.
Dec 18, 2013 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Possible break in the connector of the Force Sensor. Class II Zimmer Biomet, Inc.
Nov 26, 2013 outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... Class II Biomet, Inc.
Nov 26, 2013 G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 Investigation identified that the outer label, inner label, and patient label all have the incorr... Class II Biomet, Inc.
Oct 25, 2013 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... Class II Biomet, Inc.
Oct 10, 2013 Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... Investigation identified that the design of the drill bit may make the suture anchor difficult to... Class II Biomet, Inc.
Jun 7, 2013 REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6A... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.
Jun 7, 2013 REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ... Biomet investigation found the design of the tibial bearing creates the potential for anterior im... Class II Biomet, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.